Negative Pressure Wound Therapy - A Multi-Centered Randomized Control Trial

Early Phase 1

• Conditions: to See Whether Negative Pressure Wound Therapy Decreases Wound Infections.
• Interventions: Device: Negative Pressure Wound Therapy; Other: Standard Gauze Treatment

• Registration Number: NCT02790385
• Lead Sponsor: University of British Columbia

Brief Summary

Children with neuromuscular disorders such as cerebral palsy, children with kyphosis and post-traumatic scoliosis have higher infection rates after scoliosis surgery than healthy children who undergo scoliosis surgery. The purpose of our study is to compare the effect of NPWT on infection rates when compared to standard gauze dressing. Participants will be randomized to the "NPWT" or "standard dressing" group. We will compare infection rates between the two groups. We hypothesize participants in the "NPWT" group will have a lower infection rate.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-07
• Study Start: 2014-07
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-30
• Last Update Submitted: 2016-05-30
• Study First Posted: 2016-06-03
• Last Update Posted: 2016-06-03
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 870

Inclusion Criteria

• Male or female
• Consent/assent to participate in the study
• Undergoing posterior spinal surgery categorized as High-Risk for infection, defined as greater than 4% risk of deep or superficial infection based previous reported literature. Procedures qualifying for study are listed below:
• Kyphosis (any type)
• Posttraumatic Scoliosis
• Neuromuscular Scoliosis

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Exclusion Criteria

• Previous incisions over the operative site
• History of keloid formation
• Allergy to tape
• Does not consent/assent to participate in the study
• Previous or Active Spinal infection
• Dural tear
• Hemophiliac
• Two Stage procedure
• Unable to follow standard antibiotic protocols

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPWT	Negative Pressure Wound Therapy	subjects will undergo negative pressure wound therapy
Standard Gauze	Standard Gauze Treatment	standard method of using gauze and dressing will be utilized

Primary Outcome Measures

Name	Time	Method
Wound Infection	up to post op day 14	Wounds will be classified as prolonged discharge if they have persistent sterile drainage on post-op day 5 or after, or as "infected," if cellulitis is found at suture line (erythema \>1cm + tenderness + localized swelling + warmth). Wound assessment will be carried out by a clinical fellow on day 5 and subsequent days till discharge. Patients will also be assessed for other signs of infection such as Fever, Chills, and increase in pain or changes in appetite. Standard infection work-up will be utilized to rule in or rule out infection.

Secondary Outcome Measures

Name	Time	Method
Time for wound closure	intraoperatively	This will be measured intra-operatively in the operating room from the beginning of deep wound closure till complete skin closure either with standard treatment or by NPWT. Though this outcome measure may not appear to have much value as these surgeries are of a long duration, we considered it important from the surgeon's perspective.
Cosmetic results	12 weeks post op	(Hollander wound evaluation scale): This is a validated cosmetic scoring system \[8\], which gives a score from 0 to 6. The score addresses six clinical variables: step off borders, contour irregularities, scar width, edge inversion, excessive inflammation, and overall cosmetic appearance. Each of these categories is graded on a 0- or 1-point scale where a score of 6 is considered optimal. At 12 weeks post-op follow-up, assessment of the scar will be carried out by an independent investigator who will be blinded to which treatment group the patient belongs to.
Wound dehiscence	psot op day 5 to discharge	Any gaping of the spinal wound \> 5cm exposing subcutaneous tissue or deeper planes will be considered as indicative of wound dehiscence. This will be looked for at the 5th post- operative day during dressing change till 14 days post-op.
Foreign body reaction	12 weeks post op	Any evidence of foreign body reaction will be looked for at the two week mark and at 12 weeks post-op follow up. The presence of swelling under the wound over the suture or NPWT site in the absence of fever, significant redness and tenderness will be indicative of foreign body reaction.
Caregiver/parental satisfaction	12 weeks post op	This will analyzed on a visual analog scale (VAS)

Trial Locations

Locations (1)

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada